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NCT07670923
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Conditions: Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Sex: All
Ages: 65 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 108
Sponsor: General Hospital of Ningxia Medical University
Location: Cardiovascular and Cerebrovascular Disease Hospital, General Hospital of Ningxia Medical University Yinchuan Ningxia
Summary
At the initiation of induction for non-intubated general anesthesia, ciprofol or propofol will be administered intravenously at a rate of 10 mL/min. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale will be used to evaluate sedation depth. This study aims to assess the effects of ciprofol and propofol on hemodynamics and respiratory function in elderly patients undergoing non-intubated general anesthesia.
Eligibility Criteria
Inclusion Criteria
1. Elderly patients scheduled to undergo gastrointestinal endoscopy;
2. Aged 65-80 years;
3. American Society of Anesthesiologists (ASA) status of Ⅰ-Ⅲ; Exclusion Criteria
(1)Declined to participate in the study; (2)Had known allergies or contraindications to benzodiazepines, ciprofol, propofol, or related compounds; (3)Had a history of alcohol abuse or dependence on sedative-hypnotics drugs; (4)Severe cardiovascular diseases, including uncontrolled hypertension(SBP ≥160 mmHg or DBP ≥100 mmHg despite medical treatment) or hypotension (SBP ≤90 mmHg or DBP ≤60 mmHg), resting bradycardia (heart rate \< 45 bpm), severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within the past 6 months, third-degree atrioventricular block, and QT interval ≥ 450 ms; (5)Severe respiratory diseases, including respiratory insufficiency and chronic obstructive pulmonary disease(COPD), bronchospasm requiring treatment within the previous 3 months, acute respiratory infection accompanied by fever, wheezing, pulmonary rales or cough within the past week, predicted difficult airway(Mallampati grade Ⅳ), and baseline hypoxemia (SpO₂ \< 90%); (6)Liver, kidney, blood system, nervous system, metabolic system or mental diseases with significant clinical significance; (7)Severe gastrointestinal diseases such as gastric retention and persistent gastrointestinal bleeding; (8)Demonstrated uncooperative behavior or impaired communication ability.
Source: ClinicalTrials.gov (NCT07670923). StuddyBuddy aggregates publicly available trial information.